Specialist - Quality Operations Novartis

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

As the Special - Quality Operations at Novartis, your role involves overseeing the quality aspects of contract manufacturers for drug product/drug substance/intermediate product/raw material of ADACAP. You will be responsible for ensuring compliance with applicable ADACAP and Novartis standards, quality management systems, and relevant guidelines. Your key responsibilities include: - Developing and maintaining Quality Assurance Agreements with external partners - Qualifying and onboarding contract manufacturers, conducting regular quality risk assessments - Managing activities related to quality processes such as deviations, complaints, recalls, and stability failures - Reviewing third party...

Posted 3 days ago

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Specialist - Quality Operations Sandoz

3.0 - 7.0 years

3 - 7 Lacs

hyderabad, telangana, india

On-site

Develops and maintains a Quality Assurance Agreement in cooperation with the external partners. Responsible for the initial qualification and onboarding of contract manufacturers as well as for performing regular quality risk assessments. Ensures that all aspects of manufacturing, testing, release and distribution of drug substance/drug product/ intermediate product/material are in compliance with applicable ADACAP and Novartis standards, the effective Quality Assurance Agreement, relevant guidelines and the Quality Management System of the external partners. Manages and oversees contract manufacturer s activities related to quality processes such as deviations, complaints, recalls, counterf...

Posted 2 months ago

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